A Study to Evaluate the Safety and Immunogenicity of V710... | NCT00572910 | Trialant
NCT00572910
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Apr 3, 2015Estimated
Enrollment
206Actual
Phase
Phase 2
Conditions
Staphylococcus Aureus Infection
Interventions
Comparator: Placebo (PBO)
V710 Comparator: Placebo (PBO)
V710 Comparator: Placebo (PBO)
V710 Comparator: Placebo (PBO)
V710 Comparator: Placebo (PBO)
V710 Comparator: Placebo (PBO)
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00572910
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V710-005
Secondary IDs
ID
Type
Description
Link
2007_609
Brief Title
A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of Merck Staphylococcus Aureus Vaccine (V710) in Adult Patients With End-Stage Renal Disease on Chronic Hemodialysis
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Mar 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2008
Primary Completion Date
Jan 2010Actual
Completion Date
Jan 2010Actual
First Submitted Date
Dec 11, 2007
First Submission Date that Met QC Criteria
Dec 11, 2007
First Posted Date
Dec 13, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 20, 2011
Results First Submitted that Met QC Criteria
Jul 20, 2011
Results First Posted Date
Aug 15, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 16, 2015
Last Update Posted Date
Apr 3, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.
Detailed Description
Not provided
Conditions Module
Conditions
Staphylococcus Aureus Infection
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
206Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
V710 - Group 1
Experimental
V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Biological: V710 Comparator: Placebo (PBO)
V710 - Group 2
Experimental
V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
Biological: V710 Comparator: Placebo (PBO)
V710 - Group 3
Experimental
V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Biological: V710 Comparator: Placebo (PBO)
V710 - Group 4
Experimental
V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
Biological: V710 Comparator: Placebo (PBO)
V710 - Group 5
Experimental
V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Biological: V710 Comparator: Placebo (PBO)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Comparator: Placebo (PBO)
Biological
Group 6: Placebo (PBO / PBO / PBO)
Group 6
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination
Participants whose GMFR in anti-0657n IgG antibody concentration was measured by the LUMINEX™ assay from Baseline to 28 days after the administration of the second vaccination of V710 for the 3 groups receiving 2 doses of V710 (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.
Prevaccination to 56 days postvaccination
Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE)
Participants with Adverse Experiences (AE) / Serious Adverse Experiences (SAE) occurring Day 1 through Day 14 following vaccinations 1, 2, and 3.
Participants with specific SAEs including any vaccine-related SAEs, any SAEs involving a Staphylococcus aureus (S. aureus) infection, or any AEs leading to death occurring Day 1 through Day 360 following vaccination.
Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths.
Secondary Outcomes
Measure
Description
Time Frame
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination
Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 28 for the 3 Groups receiving 1 dose of V710 (60 mcg without MAA) Group 1 and 2 combined, (60 mcg with MAA) Group 3 and 4 combined and (90 mcg with MAA) Group 5.
Prevaccination to 28 days postvaccination
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosed with end stage kidney disease and is on hemodialysis
Female patients who are able to have children must have a negative urine pregnancy tests
Exclusion Criteria:
Developed a serious infection within the past 12 months; allergy to the components of the vaccine
Has been vaccinated with a live virus within the past 30 days or are scheduled to be vaccinated with a live virus in the next 60 days
Moustafa M, Aronoff GR, Chandran C, Hartzel JS, Smugar SS, Galphin CM, Mailloux LU, Brown E, Dinubile MJ, Kartsonis NA, Guris D. Phase IIa study of the immunogenicity and safety of the novel Staphylococcus aureus vaccine V710 in adults with end-stage renal disease receiving hemodialysis. Clin Vaccine Immunol. 2012 Sep;19(9):1509-16. doi: 10.1128/CVI.00034-12. Epub 2012 Jul 25.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
V710 (60 mcg / 60 mcg / 60 mcg)
Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
FG001
V710 (60 mcg / 60 mcg / PBO)
Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Group 6
Placebo Comparator
Placebo on Day 1, 28 and 180.
Biological: Comparator: Placebo (PBO)
V710 Comparator: Placebo (PBO)
Biological
Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA
Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA
V710 - Group 5
V710 Comparator: Placebo (PBO)
Biological
Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA
Group 4B: V710 (60 mcg / PBO / PBO) with MAA
V710 - Group 4
V710 Comparator: Placebo (PBO)
Biological
Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA
Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA
V710 - Group 3
V710 Comparator: Placebo (PBO)
Biological
Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA
Group 2B: V710 (60 mcg / PBO / PBO) without MAA
V710 - Group 2
V710 Comparator: Placebo (PBO)
Biological
Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA
Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA
V710 - Group 1
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination
Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 180 for the 3 Groups receiving 2 doses of V710 28 days apart (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.
Prevaccination to 180 days postvaccination
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination
Participants whose GMFR in 0657n-specific IgG antibody concentration from Baseline to Day 56 for the 2 Groups receiving a single dose of V710 (60 mcg without MAA followed by Placebo 28 Days later) Group 2, and (60 mcg with MAA followed by Placebo 28 days later) Group 4.
Prevaccination to 56 days postvaccination
GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints
Participants whose GMFR in 0657n-specific IgG antibody concentration from baseline through Day 360 for all groups (including Days 28, 56, 84,180, 210, 270, and 360) to assess the durability and kinetics of the immune response.
Prevaccination to 360 days post vaccination
FG002
V710 (60 mcg / PBO / 60 mcg)
Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
FG003
V710 (60 mcg / PBO / PBO)
Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
FG004
V710 (60 mcg / 60 mcg / 60 mcg) + MAA
Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
FG005
V710 (60 mcg / 60 mcg / PBO) + MAA
Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg /PBO) with MAA.
FG006
V710 (60 mcg / PBO / 60 mcg) + MAA
Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
FG007
V710 (60 mcg / PBO / PBO) + MAA
Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
FG008
V710 (90 mcg / 90 mcg / 90 mcg) + MAA
Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
FG009
V710 (90 mcg / 90 mcg / PBO) + MAA
Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
FG010
Placebo (PBO / PBO / PBO)
Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
FG00019 subjects
FG00118 subjects
FG00219 subjects
FG00318 subjects
FG00419 subjects
FG00519 subjects
FG00619 subjects
FG00719 subjects
FG00819 subjects
FG00919 subjects
FG01018 subjects
COMPLETED
FG00015 subjects
FG00115 subjects
FG00217 subjects
FG00314 subjects
FG00417 subjects
FG00516 subjects
FG00615 subjects
FG00715 subjects
FG00816 subjects
FG00913 subjects
FG01015 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0022 subjects
FG0034 subjects
FG0042 subjects
FG0053 subjects
FG0064 subjects
FG0074 subjects
FG0083 subjects
FG0096 subjects
FG0103 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0064 subjects
FG0072 subjects
FG0081 subjects
FG0093 subjects
FG0102 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
V710 (60 mcg / 60 mcg)
Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
BG001
V710 (60 mcg / PBO)
Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28.
BG002
V710 (60 mcg / 60 mcg) + MAA
Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
BG003
V710 (60 mcg / PBO) + MAA
Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28.
BG004
V710 (90 mcg / 90 mcg) + MAA
Participants who were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
BG005
Placebo (PBO / PBO)
Participants who were vaccinated with Placebo on Day 1 and Day 28.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00037
BG00137
BG00238
BG00338
BG00438
BG00518
BG006206
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
<50 years of age
Title
Measurements
BG00010
BG00114
BG00214
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00115
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination
Participants whose GMFR in anti-0657n IgG antibody concentration was measured by the LUMINEX™ assay from Baseline to 28 days after the administration of the second vaccination of V710 for the 3 groups receiving 2 doses of V710 (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Prevaccination to 56 days postvaccination
ID
Title
Description
OG000
V710 (60 mcg Without MAA) - Group 1
Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
OG001
V710 (60 mcg With MAA) - Group 3
Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
OG002
V710 (90 mcg With MAA) - Group 5
Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
Units
Counts
Participants
OG00036
OG00137
OG00236
Title
Denominators
Categories
Title
Measurements
OG00018.9(13.7 to 26.1)
OG00115.1(11.0 to 20.8)
OG00217.8(13.0 to 24.3)
Secondary
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination
Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 28 for the 3 Groups receiving 1 dose of V710 (60 mcg without MAA) Group 1 and 2 combined, (60 mcg with MAA) Group 3 and 4 combined and (90 mcg with MAA) Group 5.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Prevaccination to 28 days postvaccination
ID
Title
Description
OG000
V710 - Group 1 and 2
Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Participants Group 2 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
OG001
V710 - Group 3 and 4
Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Participants in Group 4 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
OG002
V710 - Group 5
Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Secondary
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination
Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 180 for the 3 Groups receiving 2 doses of V710 28 days apart (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Prevaccination to 180 days postvaccination
ID
Title
Description
OG000
V710 - Group 1
Participants in Group 1 were vaccinated V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
OG001
V710 - Group 3
Participants in Group 2 were vaccinated V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
OG002
V710 - Group 5
Participants in Group 5 were vaccinated V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Units
Secondary
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination
Participants whose GMFR in 0657n-specific IgG antibody concentration from Baseline to Day 56 for the 2 Groups receiving a single dose of V710 (60 mcg without MAA followed by Placebo 28 Days later) Group 2, and (60 mcg with MAA followed by Placebo 28 days later) Group 4.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Prevaccination to 56 days postvaccination
ID
Title
Description
OG000
V710 - Group 2
Participants in Group 2 were vaccinated V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
OG001
V710 - Group 4
Participants in Group 4 were vaccinated V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
Units
Counts
Participants
OG000
Secondary
GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints
Participants whose GMFR in 0657n-specific IgG antibody concentration from baseline through Day 360 for all groups (including Days 28, 56, 84,180, 210, 270, and 360) to assess the durability and kinetics of the immune response.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Prevaccination to 360 days post vaccination
ID
Title
Description
OG000
V710 (60 mcg / 60 mcg / 60 mcg)
Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
OG001
V710 (60 mcg / 60 mcg / PBO)
Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
OG002
V710 (60 mcg / PBO / 60 mcg)
Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
OG003
V710 (60 mcg / PBO / PBO)
Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
Primary
Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE)
Participants with Adverse Experiences (AE) / Serious Adverse Experiences (SAE) occurring Day 1 through Day 14 following vaccinations 1, 2, and 3.
Participants with specific SAEs including any vaccine-related SAEs, any SAEs involving a Staphylococcus aureus (S. aureus) infection, or any AEs leading to death occurring Day 1 through Day 360 following vaccination.
Posted
Number
Participants
Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths.
ID
Title
Description
OG000
V710 (60 mcg / 60 mcg / 60 mcg)
Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
OG001
V710 (60 mcg / 60 mcg / PBO)
Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
OG002
V710 (60 mcg / PBO / 60 mcg)
Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
OG003
V710 (60 mcg / PBO / PBO)
Time Frame
Day 1-14 following each vaccination for all AEs (non-serious or serious). Day 1-360 for specific serious AEs (vaccine-related, resulting in death, or involving a S. aureus infection).
Description
The table "Serious Adverse Events" displays serious AEs reported throughout the study duration (Days 1-360). The table "Other Adverse Events" displays AEs reported Day 1-14 following any vaccination.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
V710 (60 mcg / 60 mcg / 60 mcg)
Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
2
18
8
18
EG001
V710 (60 mcg / 60 mcg / PBO)
Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
3
18
9
18
EG002
V710 (60 mcg / PBO / 60 mcg)
Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
2
19
5
19
EG003
V710 (60 mcg / PBO / PBO)
Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
5
18
4
18
EG004
V710 (60 mcg / 60 mcg / 60 mcg) + MAA
Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
0
19
9
19
EG005
V710 (60 mcg / 60 mcg / PBO) + MAA
Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
5
18
10
18
EG006
V710 (60 mcg / PBO / 60 mcg) + MAA
Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
4
19
10
19
EG007
V710 (60 mcg / PBO / PBO) + MAA
Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
2
18
8
18
EG008
V710 (90 mcg / 90 mcg / 90 mcg) + MAA
Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
2
17
9
17
EG009
V710 (90 mcg / 90 mcg / PBO) + MAA
Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
5
19
10
19
EG010
Placebo (PBO / PBO / PBO)
Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
3
18
7
18
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coagulopathy
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG0030 events0 affected18 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected19 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected18 at risk
Arrhythmia
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Death
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Enterococcal infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Gangrene
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Osteomyelitis bacterial
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Sepsis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Arteriovenous fistula occlusion
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected19 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected19 at risk
EG003
Petit mal epilepsy
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Shock
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG0030 events0 affected18 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected19 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected19 at risk
EG0102 events1 affected18 at risk
Palpitations
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Eye irritation
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Vision blurred
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Sensitivity of teeth
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Asthenia
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Chest discomfort
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Chills
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Device malfunction
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected19 at risk
EG003
Feeling hot
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Induration
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Injection site dryness
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Injection site erythema
General disorders
MedDRA 13.0
Systematic Assessment
EG0004 events3 affected18 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Injection site haematoma
General disorders
MedDRA 13.0
Systematic Assessment
EG0002 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Injection site mass
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Injection site pain
General disorders
MedDRA 13.0
Systematic Assessment
EG0006 events5 affected18 at risk
EG0016 events5 affected18 at risk
EG0021 events1 affected19 at risk
EG003
Injection site paraesthesia
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Injection site pruritus
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Injection site swelling
General disorders
MedDRA 13.0
Systematic Assessment
EG0004 events2 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Injection site warmth
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pain
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pyrexia
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Ear infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Orchitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Arteriovenous fistula site complication
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Shunt thrombosis
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pulse absent
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Venous pressure increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected19 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected19 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected19 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected19 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected19 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected19 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Hypotension
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected19 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D013203
Staphylococcal Infections
Ancestor Terms
ID
Term
D016908
Gram-Positive Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
1 subjects
FG0053 subjects
FG0060 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0101 subjects
5
BG00414
BG0056
BG00663
>=50 years of age
Title
Measurements
BG00027
BG00123
BG00224
BG00333
BG00424
BG00512
BG006143
19
BG00314
BG00416
BG0057
BG00684
Male
BG00024
BG00122
BG00219
BG00324
BG00422
BG00511
BG006122
Units
Counts
Participants
OG00073
OG00174
OG00236
Title
Denominators
Categories
Title
Measurements
OG00011.9± 9.0(9.0 to 15.6)
OG00112.9± 12.9(9.8 to 16.9)
OG00212.9(8.8 to 18.8)
Counts
Participants
OG00036
OG00137
OG00236
Title
Denominators
Categories
Title
Measurements
OG0008.5(6.2 to 11.8)
OG0015.7(4.2 to 7.9)
OG0027.6(5.5 to 10.6)
37
OG00137
Title
Denominators
Categories
Title
Measurements
OG0009.6(7.1 to 13.1)
OG00111.8(8.6 to 16.1)
OG004
V710 (60 mcg / 60 mcg / 60 mcg) + MAA
Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
OG005
V710 (60 mcg / 60 mcg / PBO) + MAA
Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
OG006
V710 (60 mcg / PBO / 60 mcg) + MAA
Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
OG007
V710 (60 mcg / PBO / PBO) + MAA
Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
OG008
V710 (90 mcg / 90 mcg / 90 mcg) + MAA
Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
OG009
V710 (90 mcg / 90 mcg / PBO) + MAA
Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
OG010
Placebo (PBO / PBO / PBO)
Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
Units
Counts
Participants
OG00018
OG00118
OG00219
OG00318
OG00419
OG00518
OG00619
OG00718
OG00817
OG00919
OG01018
Title
Denominators
Categories
Day 1
Title
Measurements
OG00022.2(13.6 to 36.4)
OG00119.9(11.7 to 34.1)
OG00236.3(24.3 to 54.0)
OG00324.6(14.1 to 42.8)
OG00426.9(16.6 to 43.8)
OG00533.7(20.1 to 56.8)
OG00636.6(23.6 to 56.7)
OG00726.6(16.9 to 41.9)
OG00824.4(15.1 to 39.3)
OG00925.4(17.4 to 37.1)
OG01030.2(20.7 to 44.0)
Day 28
Title
Measurements
OG00019.4(8.0 to 47.0)
OG00113.4(8.2 to 21.9)
OG0029.2(5.1 to 16.6)
OG003
Day 56
Title
Measurements
OG00030.3(17.7 to 51.9)
OG00114.6(8.6 to 24.8)
OG00210.3(5.9 to 18.0)
OG003
Day 84
Title
Measurements
OG00026.5(16.2 to 43.3)
OG00112.1(7.1 to 20.5)
OG0027.8(4.6 to 13.1)
OG003
Day 180
Title
Measurements
OG00013.0(7.5 to 22.6)
OG0017.3(4.9 to 11.1)
OG0024.0(2.4 to 6.5)
OG003
Day 210
Title
Measurements
OG00013.6(7.8 to 23.8)
OG0015.6(3.4 to 9.3)
OG0027.0(4.4 to 11.0)
OG003
Day 270
Title
Measurements
OG0008.7(5.5 to 13.6)
OG0014.0(2.6 to 6.1)
OG0025.5(3.5 to 8.7)
OG003
Day 360
Title
Measurements
OG0005.9(3.9 to 8.8)
OG0013.4(1.8 to 6.3)
OG0023.9(2.6 to 5.8)
OG003
Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
OG004
V710 (60 mcg / 60 mcg / 60 mcg) + MAA
Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
OG005
V710 (60 mcg / 60 mcg / PBO) + MAA
Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
OG006
V710 (60 mcg / PBO / 60 mcg) + MAA
Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
OG007
V710 (60 mcg / PBO / PBO) + MAA
Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
OG008
V710 (90 mcg / 90 mcg / 90 mcg) + MAA
Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
OG009
V710 (90 mcg / 90 mcg / PBO) + MAA
Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
OG010
Placebo (PBO / PBO / PBO)
Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).